Robotic surgical system with sterile surgical adaptor
Summary by NHIP
Robotic surgical drape system
The system uses a sterile drape with an integrated adaptor to shield a manipulator arm while connecting to a surgical instrument. The adaptor features a spring-loaded input, insert-molded electrical contacts, and a disk with apertures and teeth for engagement.
Claim Score by NHIP
Abstract
A sterile drape with integrated sterile adaptor, a telerobotic surgical system, and method of use are provided for draping portions of a telerobotic surgical system to maintain a sterile barrier between the sterile surgical field and the non-sterile robotic system while also providing an interface for transferring mechanical and electrical energy and signals.

Term
Term ended
Expired 24 November 2020, 5.8 years ago.
- Priority
- Filed
- Granted
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- Today
12 claims: 3 independent, 9 dependent
- 1Broadest claimClaim Score 76, broad(NHIP)A robotic surgical system for performing a procedure within a sterile field, the system comprising:a manipulator arm in a non-sterile field, wherein the manipulator arm includes a spring loaded input;a surgical instrument in the sterile field;and a sterile drape covering the manipulator arm to shield the manipulator arm from the sterile field, the sterile drape including a sterile adaptor configured to engage the spring loaded input of the manipulator arm and further configured to engage the surgical instrument.
- 8A robotic surgical system for performing a procedure within a sterile field, the system comprising:a manipulator arm in a non-sterile field;a surgical instrument in the sterile field;and a sterile drape covering the manipulator arm to shield the manipulator arm from the sterile field, the sterile drape including a sterile adaptor for interfacing between the manipulator arm and the surgical instrument, wherein the manipulator arm includes an adaptor receiving portion that has spring loaded inputs for engaging the adaptor.
- 9A method of coupling a surgical instrument to a manipulator arm of a robotic surgical system, the method comprising:providing a sterile drape including: an exterior surface adjacent to a sterile field for performing a surgical procedure;an interior surface forming a cavity for receiving a non-sterile portion of the robotic surgical system;and a sterile adaptor for interfacing between a manipulator arm in the non-sterile field and a surgical instrument in the sterile field;positioning the sterile drape over the manipulator arm;placing the adaptor over a receiving portion of the manipulator arm and engaging a disk of the adaptor with a spring loaded input of the receiving portion of the manipulator arm;and coupling the adaptor with the surgical instrument.
Independent claims3
91 paragraphs in 6 sections, as filed
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. patent application Ser. No. 10/922,346, filed Aug. 19, 2004, now U.S. Pat. No. 7,357,774 which is a continuation of U.S. patent application Ser. No. 10/004,399, filed Oct. 30, 2001, now abandoned, which is a continuation of U.S. patent application Ser. No. 09/406,360, filed Sep. 28, 1999, now U.S. Pat. No. 6,346,072, which is a continuation of U.S. patent application Ser. No. 08/975,617, filed Nov. 21, 1997, now U.S. Pat. No. 6,132,368, which claimed priority to U.S. Provisional Application No. 60/033,321, filed Dec. 12, 1996, the full disclosures of which are hereby incorporated by reference for all purposes.
This application is also a continuation-in-part of pending U.S. patent application Ser. Nos. 11/240,087 and 11/240,113, both filed Sep. 30, 2005, the full disclosures of which are hereby incorporated by reference for all purposes.
This application is related to U.S. Provisional Application No. 60/752,472, filed Dec. 20, 2005, the full disclosure of which (including all references incorporated by reference therein) is incorporated by reference herein for all purposes.
This application is also related to U.S. Provisional Application No. 60/752,755, filed Dec. 20, 2005, the full disclosure of which (including all references incorporated by reference therein) is incorporated by reference herein for all purposes.
TECHNICAL FIELD
The present invention relates generally to surgical robot systems and, more particularly, to a disposable sterile adaptor of a sterile drape for covering portions of the surgical robot system.
BACKGROUND
In robotically-assisted or telerobotic surgery, the surgeon typically operates a master controller to remotely control the motion of surgical instruments at the surgical site from a location that may be remote from the patient (e.g., across the operating room, in a different room or a completely different building from the patient). The master controller usually includes one or more hand input devices, such as joysticks, exoskeletal gloves or the like, which are coupled to the surgical instruments with servo motors for articulating the instruments at the surgical site. The servo motors are typically part of an electromechanical device or surgical manipulator (“the slave”) that supports and controls the surgical instruments that have been introduced directly into an open surgical site or through trocar sleeves into a body cavity, such as the patient's abdomen. During the operation, the surgical manipulator provides mechanical articulation and control of a variety of surgical instruments, such as tissue graspers, needle drivers, electrosurgical cautery probes, etc., that each perform various functions for the surgeon, e.g., holding or driving a needle, grasping a blood vessel, or dissecting, cauterizing or coagulating tissue.
This new method of performing telerobotic surgery through remote manipulation has, of course, created many new challenges. One such challenge results from the fact that a portion of the electromechanical surgical manipulator will be in direct contact with the surgical instruments, and will also be positioned adjacent the operation site. Accordingly, the surgical manipulator may become contaminated during surgery and is typically disposed of or sterilized between operations. From a cost perspective, it would be preferable to sterilize the device. However, the servo motors, sensors, encoders, and electrical connections that are necessary to robotically control the motors typically cannot be sterilized using conventional methods, e.g., steam, heat and pressure, or chemicals, because the system parts would be damaged or destroyed in the sterilization process.
A sterile drape has been previously used to cover the surgical manipulator and has included holes through which an adaptor (for example a wrist unit adaptor or a cannula adaptor) would enter the sterile field. However, this disadvantageously requires detachment and sterilization of the adaptors after each procedure and also causes a greater likelihood of contamination through the holes in the drape.
Yet another challenge with telerobotic surgery systems is that a surgeon will typically employ a large number of different surgical instruments/tools during a procedure. Since the number of manipulator arms are limited due to space constraints and cost, many of these surgical instruments will be attached and detached from the same manipulator arm a number of times during an operation. In laparoscopic procedures, for example, the number of entry ports into the patient's abdomen is generally limited during the operation because of space constraints as well as a desire to avoid unnecessary incisions in the patient. Thus, a number of different surgical instruments will typically be introduced through the same trocar sleeve during the operation. Likewise, in open surgery, there is typically not enough room around the surgical site to position more than one or two surgical manipulators, and so the surgeon's assistant will be compelled to frequently remove instruments from the manipulator arm and exchange them with other surgical tools.
What is needed, therefore, are improved telerobotic systems and methods for remotely controlling surgical instruments at a surgical site on a patient. In particular, these systems and methods should be configured to minimize the need for sterilization to improve cost efficiency while also protecting the system and the surgical patient. In addition, these systems and methods should be designed to minimize instrument exchange time and difficulty during the surgical procedure <b>316</b>. Accordingly, a sterile adaptor and a system for robotic surgery having improved efficiency and cost-effectiveness is highly desirable.
SUMMARY
The present invention provides a sterile adaptor integrated with a sterile drape for draping portions of a telerobotic surgical system to maintain a sterile barrier between the sterile surgical field and the non-sterile robotic system while also providing an interface for transferring mechanical and electrical energy and signals.
In accordance with an embodiment of the present invention, a sterile drape to cover a non-sterile portion of a robotic surgical system is provided, the sterile drape comprising: an exterior surface adjacent to a sterile field for performing a surgical procedure; an interior surface forming a cavity for receiving the non-sterile portion of the robotic surgical system; and a sterile adaptor for interfacing between a non-sterile manipulator arm of the robotic surgical system and a surgical instrument in the sterile field.
In accordance with another embodiment of the present invention, a robotic surgical system for performing a procedure within a sterile field is provided, the system comprising: a manipulator arm in a non-sterile field; a surgical instrument in the sterile field; and a sterile drape covering the manipulator arm to shield the manipulator arm from the sterile field, the sterile drape including a sterile adaptor for interfacing between the manipulator arm and the surgical instrument.
In accordance with yet another embodiment of the present invention, a method of coupling a surgical instrument to a manipulator arm of a robotic surgical system is provided, the method comprising: providing a sterile drape including an exterior surface adjacent to a sterile field for performing a surgical procedure, an interior surface forming a cavity for receiving a non-sterile portion of the robotic surgical system, and a sterile adaptor for interfacing between a manipulator arm in the non-sterile field and a surgical instrument in the sterile field; positioning the sterile drape over the manipulator arm; coupling the adaptor with a receiving portion of the manipulator arm; and coupling the adaptor with the surgical instrument.
Advantageously, the present invention provides for improved installation and interfacing of a surgical instrument with a manipulator arm, improved robustness of the sterile field, and increased visualization of the patient by reducing the size of the drapes with more form fitting features. By providing a disposable adaptor, cost is reduced by the use of less expensive materials, while at the same time robustness and dependability of the apparatus is increased.
The scope of the invention is defined by the claims, which are incorporated into this section by reference. A more complete understanding of embodiments of the present invention will be afforded to those skilled in the art, as well as a realization of additional advantages thereof, by a consideration of the following detailed description of one or more embodiments. Reference will be made to the appended sheets of drawings that will first be described briefly.
BRIEF DESCRIPTION OF THE DRAWINGS
<figref idref="DRAWINGS">FIG. 1</figref> is a schematic view of an operating room, illustrating a telerobotic surgical system and method in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 2</figref> is an enlarged view of the operating room of <figref idref="DRAWINGS">FIG. 1</figref> illustrating a pair of mounting joints coupled to an operating table according to the present invention.
<figref idref="DRAWINGS">FIG. 3A</figref> is a perspective view of a robotic surgical manipulator that is partially covered by a sterile drape in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 3B</figref> is a perspective view of the robotic surgical manipulator of <figref idref="DRAWINGS">FIG. 3A</figref> without the sterile drape to illustrate a multiple degree of freedom arm coupling a driving assembly with a wrist unit and a surgical tool.
<figref idref="DRAWINGS">FIG. 4</figref> illustrates the robotic surgical manipulator of <figref idref="DRAWINGS">FIGS. 3A-3B</figref> incorporating a camera and endoscope for viewing the surgical site.
<figref idref="DRAWINGS">FIG. 5</figref> is a partial view of the robotic manipulator of <figref idref="DRAWINGS">FIGS. 3A-3B</figref>, illustrating mechanical and electrical couplings between the arm and the wrist unit.
<figref idref="DRAWINGS">FIG. 6</figref> is a partially cut-away sectional view of a forearm and a carriage of the manipulator of <figref idref="DRAWINGS">FIGS. 3A and 3B</figref>.
<figref idref="DRAWINGS">FIG. 7</figref> is a perspective view of the wrist unit in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 8</figref> is a side cross-sectional view of a portion of the robotic manipulator, illustrating the arm and the drive assembly.
<figref idref="DRAWINGS">FIG. 9A</figref> is a perspective view of a sterile drape with installed surgical instrument on an instrument sterile adaptor fully covering a robotic surgical manipulator in accordance with one embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 9B</figref> is a side view of the surgical manipulator, installed surgical instrument, and integrated instrument sterile adaptor of <figref idref="DRAWINGS">FIG. 9A</figref> without a sterile drape portion.
<figref idref="DRAWINGS">FIG. 10A</figref> is a perspective view of the sterile drape of <figref idref="DRAWINGS">FIG. 9A</figref> without the surgical instrument and surgical accessory in accordance with another embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 10B</figref> is a perspective view of the surgical manipulator and accessory clamp of <figref idref="DRAWINGS">FIG. 10A</figref> without the sterile drape.
<figref idref="DRAWINGS">FIGS. 11A-11L</figref> are views of a PSM drape with integrated instrument sterile adaptor in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIGS. 12A</figref>, <b>12</b>B, and <b>12</b>C illustrate a top perspective view, a bottom perspective view, and a sectional view of the ISA, respectively, in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 13</figref> illustrates a close up section view of an electrical contact of the ISA in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIGS. 14A and 14B</figref> illustrate close up perspective top and bottom views of a disc of the ISA, respectively, in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIGS. 15A and 15B</figref> illustrate top and bottom perspective views of a top retractor plate of the ISA in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 16</figref> illustrates a perspective view of an adaptor receiving portion of a manipulator in accordance with an embodiment of the present invention
<figref idref="DRAWINGS">FIGS. 17A through 17F</figref> show installation/engagement of the ISA to the adaptor receiving portion, installation/engagement of the surgical instrument to the ISA, and removal of the surgical instrument from the ISA in accordance with an embodiment of the present invention.
Embodiments of the present invention and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures. It should also be appreciated that the figures may not be necessarily drawn to scale.
DETAILED DESCRIPTION
The present invention provides a multi-component system and method for performing robotically-assisted surgical procedures on a patient, particularly including open surgical procedures, neurosurgical procedures, such as stereotaxy, and endoscopic procedures, such as laparoscopy, arthroscopy, thoracoscopy and the like. The system and method of the present invention is particularly useful as part of a telerobotic surgical system that allows the surgeon to manipulate the surgical instruments through a servomechanism from a remote location from the patient. To that end, the manipulator apparatus or slave of the present invention will usually be driven by a kinematically-equivalent master to form a telepresence system with force reflection. A description of a suitable slave-master system can be found in U.S. patent application Ser. No. 08/517,053, filed Aug. 21, 1995, the complete disclosure of which is incorporated herein by reference for all purposes.
Referring to the drawings in detail, wherein like numerals indicate like elements, a telerobotic surgical system <b>2</b> is illustrated according to an embodiment of the present invention. As shown in <figref idref="DRAWINGS">FIG. 1</figref>, telerobotic system <b>2</b> generally includes one or more surgical manipulator assemblies <b>4</b> mounted to or near an operating table O, and a control assembly <b>6</b> for allowing the surgeon S to view the surgical site and to control the manipulator assemblies <b>4</b>. The system <b>2</b> will also include one or more viewing scope assemblies <b>19</b> and a plurality of surgical instrument assemblies <b>20</b> adapted for being removably coupled to manipulator assemblies <b>4</b> (discussed in detail below). Telerobotic system <b>2</b> usually includes at least two manipulator assemblies <b>4</b> and preferably three manipulator assemblies <b>4</b>. The exact number of manipulator assemblies <b>4</b> will depend on the surgical procedure and the space constraints within the operating room among other factors. As discussed in detail below, one of the assemblies <b>4</b> will typically operate a viewing scope assembly <b>19</b> (e.g., in endoscopic procedures) for viewing the surgical site, while the other manipulator assemblies <b>4</b> operate surgical instruments <b>20</b> for performing various procedures on the patient P.
Control assembly <b>6</b> may be located at a surgeon's console C which is usually located in the same room as operating table O so that the surgeon may speak to his/her assistant(s) A and directly monitor the operating procedure. However, it should be understood that the surgeon S can be located in a different room or a completely different building from the patient P. Control assembly <b>6</b> generally includes a support <b>8</b>, a monitor <b>10</b> for displaying an image of the surgical site to the surgeon S, and one or more controller(s) <b>12</b> for controlling manipulator assemblies <b>4</b>. Controller(s) <b>12</b> may include a variety of input devices, such as joysticks, gloves, trigger-guns, hand-operated controllers, voice recognition devices or the like. Preferably, controller(s) <b>12</b> will be provided with the same degrees of freedom as the associated surgical instrument assemblies <b>20</b> to provide the surgeon with telepresence, or the perception that the controller(s) <b>12</b> are integral with the instruments <b>20</b> so that the surgeon has a strong sense of directly controlling instruments <b>20</b>. Position, force, and tactile feedback sensors (not shown) may also be employed on instrument assemblies <b>20</b> to transmit position, force, and tactile sensations from the surgical instrument back to the surgeon's hands as he/she operates the telerobotic system. One suitable system and method for providing telepresence to the operator is described in U.S. patent application Ser. No. 08/517,053, filed Aug. 21, 1995, which has previously been incorporated herein by reference.
Monitor <b>10</b> will be suitably coupled to the viewing scope assembly <b>19</b> such that an image of the surgical site is provided adjacent the surgeon's hands on surgeon console C. Preferably, monitor <b>10</b> will display an inverted image on a display <b>18</b> that is oriented so that the surgeon feels that he or she is actually looking directly down onto the operating site. To that end, an image of the surgical instruments <b>20</b> appears to be located substantially where the operator's hands are located even though the observation points (i.e., the endoscope or viewing camera) may not be from the point of view of the image. In addition, the real-time image is preferably transformed into a perspective image such that the operator can manipulate the end effector and the hand control as if viewing the workspace in substantially true presence. By true presence, it is meant that the presentation of an image is a true perspective image simulating the viewpoint of an operator that is physically manipulating the surgical instruments <b>20</b>. Thus, a controller (not shown) transforms the coordinates of the surgical instruments <b>20</b> to a perceived position so that the perspective image is the image that one would see if the camera or endoscope was located directly behind the surgical instruments <b>20</b>. A suitable coordinate transformation system for providing this virtual image is described in U.S. patent application Ser. No. 08/239,086, filed May 5, 1994, now U.S. Pa. No. 5,631,973, the complete disclosure of which is incorporated herein by reference for all purposes.
As shown in <figref idref="DRAWINGS">FIG. 1</figref>, a servomechanism <b>16</b> is provided for transferring the mechanical motion of controllers <b>12</b> to manipulator assemblies <b>4</b>. Servomechanism <b>16</b> may be separate from, or integral with manipulator assemblies <b>4</b>. Servomechanism <b>16</b> will usually provide force and torque feedback from the surgical instruments <b>20</b> to the hand-operated controllers <b>12</b>. In addition, servomechanism <b>16</b> will include a safety monitoring controller (not shown) that may freeze or at least inhibit all robot motion in response to recognized conditions (e.g., exertion of excessive force on the patient, “running away” of the manipulator assemblies <b>4</b>, etc.). The servomechanism preferably has a servo bandwidth with a 3 dB cut off frequency of at least 10 hz so that the system can quickly and accurately respond to the rapid hand motions used by the surgeon. To operate effectively with this system, manipulator assemblies <b>4</b> have a relatively low inertia and the drive motors <b>170</b> (see <figref idref="DRAWINGS">FIG. 8</figref>) have relatively low ratio gear or pulley couplings. Any suitable conventional or specialized servomechanism may be used in the practice of the present invention, with those incorporating force and torque feedback being particularly preferred for telepresence operation of the system.
Referring to <figref idref="DRAWINGS">FIG. 7</figref>, surgical instrument assemblies <b>20</b> each include a wrist unit <b>22</b> and a surgical tool <b>24</b> (<figref idref="DRAWINGS">FIGS. 3A and 3B</figref>) removably attached to wrist unit <b>22</b>. As discussed in detail below, each wrist unit <b>22</b> generally includes an elongate shaft <b>56</b> having a proximal cap <b>58</b> and a distal wrist <b>60</b> pivotally coupled to surgical tool <b>24</b>. Each wrist unit <b>22</b> is substantially the same, and will have different or the same surgical tools <b>24</b> attached thereto, depending on the requirements of the surgical procedure. Alternatively, wrist units <b>22</b> may have specialized wrists <b>60</b> designed for individual surgical tools <b>24</b> so that the wrist units <b>22</b> may be used with conventional tools <b>24</b>. As shown in <figref idref="DRAWINGS">FIG. 1</figref>, the instrument assemblies <b>20</b> are usually assembled onto a table T or other suitable support adjacent the operating table O. According to a method of the present invention (described below), wrist units <b>22</b> and their associated surgical tools <b>24</b> can be quickly exchanged during the surgical procedure by coupling and decoupling wrist unit shafts <b>56</b> from manipulator assemblies <b>4</b>.
Referring to <figref idref="DRAWINGS">FIG. 2</figref>, each manipulator assembly <b>4</b> is preferably mounted to operating table O by a mounting joint <b>30</b>. Mounting joints <b>30</b> provide a number of degrees of freedom (preferably at least 5) to assemblies <b>4</b>, and they include a brake (not shown) so that assemblies <b>4</b> can be fixed at a suitable position and orientation relative to the patient. Joints <b>30</b> are mounted to a receptacle <b>32</b> for mounting joints <b>30</b> to operating table O, and for connecting each manipulator assembly <b>4</b> to servomechanism <b>16</b>. In addition, receptacle <b>32</b> may connect joints <b>30</b> to other systems, such as an RF electrical power source, a suction-irrigation system, etc. Receptacle <b>32</b> includes a mounting arm <b>34</b> that is slidably disposed along an outer rail <b>36</b> of operating table O. Manipulator assemblies <b>4</b> may also be positioned over the operating table O with other mechanisms. For example, the system may incorporate a support system (coupled to the ceiling or a wall of the operating room) that moves and holds one or more manipulator assemblies <b>4</b> over the patient.
Referring now to <figref idref="DRAWINGS">FIGS. 3-8</figref>, manipulator assembly <b>4</b> will be described in further detail. Manipulator assembly <b>4</b> is a three-component apparatus that includes a non-sterile drive and control component, a sterilizable end effector or surgical tool (i.e., surgical instrument assembly <b>20</b>), and an intermediate connector component. The intermediate connector includes mechanical elements for coupling the surgical tool <b>24</b> with the drive and control component, and for transferring motion from the drive component to the surgical tool <b>24</b>. As shown in <figref idref="DRAWINGS">FIG. 3B</figref>, the drive and control component generally includes a drive assembly <b>40</b> and a multiple degree of freedom robotic arm <b>42</b> coupled to a mounting bracket <b>44</b>, which is adapted for mounting onto mounting joints <b>30</b> (<figref idref="DRAWINGS">FIG. 2</figref>). Preferably, drive assembly <b>40</b> and robotic arm <b>42</b> are pivotally coupled to bracket <b>44</b> about an X-axis, which extends through a remote center of spherical rotation <b>45</b> (see <figref idref="DRAWINGS">FIG. 8</figref>, discussed in further detail below). Manipulator assembly <b>4</b> further includes a forearm assembly <b>46</b> fixed to a distal end <b>48</b> of arm <b>42</b>, and a wrist unit adaptor <b>52</b> coupled to forearm assembly <b>46</b> for mounting wrist unit <b>22</b> and surgical tool <b>24</b> to manipulator assembly <b>4</b>.
For endoscopic procedures, manipulator assembly <b>4</b> additionally includes a cannula adaptor <b>64</b> attached to a lower portion of forearm <b>46</b> for mounting a cannula <b>66</b> to manipulator assembly <b>4</b>. Alternatively, cannula <b>66</b> may be an integral cannula (not shown) that is built into forearm assembly <b>46</b> (i.e., non-removable). Cannula <b>66</b> may include a force sensing element (not shown), such as a strain gauge or force-sensing resistor, mounted to an annular bearing within cannula <b>66</b>. The force sensing bearing supports surgical tool <b>24</b> during surgery, allowing the tool to rotate and move axially through the central bore of the bearing. In addition, the bearing transmits lateral forces exerted by the surgical tool <b>24</b> to the force sensing element, which is connected to servomechanism <b>16</b> for transmitting these forces to controller(s) <b>12</b>. In this manner, forces acting on surgical tools <b>24</b> can be detected without disturbances from forces acting on cannula <b>66</b>, such as the tissue surrounding the surgical incision, or by gravity and inertial forces acting on manipulator assembly <b>4</b>. This facilitates the use of manipulator assembly <b>4</b> in a robotic system because the surgeon will directly sense the forces acting against the surgical tool <b>24</b>.
As shown in <figref idref="DRAWINGS">FIG. 3A</figref>, manipulator assembly <b>4</b> further includes a sterile drape <b>70</b> sized to cover substantially the entire manipulator assembly <b>4</b>. Drape <b>70</b> has a pair of holes <b>72</b>, <b>74</b> sized and arranged so that wrist unit adaptor <b>52</b> and cannula adaptor <b>64</b> may extend through holes <b>72</b>, <b>74</b> to mount wrist unit <b>22</b> and cannula <b>66</b> to manipulator assembly <b>4</b>. Sterile drape <b>70</b> comprises a material configured to effectively shield manipulator assembly <b>4</b> from the surgical site so that most of the components of assembly <b>4</b> (i.e., arm <b>42</b>, drive assembly <b>40</b> and forearm assembly <b>46</b>) do not have to be sterilized prior to, or following the surgical procedure.
As shown in <figref idref="DRAWINGS">FIG. 3A</figref>, wrist unit adaptor <b>52</b> and cannula adaptor <b>64</b> extend through holes <b>72</b>, <b>74</b> of drape <b>70</b> so that forearm assembly <b>46</b> and the remainder of manipulator assembly <b>4</b> remain shielded from the patient during the procedure. In one embodiment, wrist unit adaptor <b>52</b> and cannula adaptor <b>64</b> are manufactured as reusable components that will be sterilized because these components extend into the sterile field of the surgical site. Wrist unit and cannula adapters <b>52</b>, <b>64</b> may be sterilized by normal methods, i.e., steam, heat and pressure, chemicals and the like. Referring again to <figref idref="DRAWINGS">FIG. 3B</figref>, wrist unit adaptor <b>52</b> includes an opening <b>80</b> for receiving shaft <b>56</b> of wrist unit <b>22</b>. As discussed in detail below, shaft <b>56</b> can be laterally urged through opening <b>80</b> and snap-fit into adaptor <b>52</b> such that the non-exposed portion of wrist unit adaptor <b>52</b> remains sterile (i.e., remains on the sterile side of drape <b>70</b> opposite the sterile field). Wrist unit adaptor <b>52</b> may also include a latch (not shown) for securing wrist unit <b>22</b> therein. Similarly, cannula adaptor <b>64</b> includes an opening <b>82</b> for snap fitting cannula <b>66</b> thereto such that the non-exposed portion of adaptor <b>64</b> remains sterile during the surgical procedure.
As shown in <figref idref="DRAWINGS">FIG. 4</figref>, wrist unit adaptor <b>52</b> may also be configured to receive a viewing scope <b>100</b> for viewing the surgical site. For endoscopic procedures, viewing scope <b>100</b> can be a conventional endoscope, which typically includes a rigid, elongated tube <b>102</b> containing a lens system (not shown) and a camera mount <b>104</b> at the proximal end of the tube <b>102</b>. A small video camera <b>106</b> is preferably attached to the camera mount <b>104</b> and connected to video monitor <b>10</b> to provide a video image of the procedure. Preferably, the scope <b>100</b> has a distal end (not shown) configured to allow lateral or angled viewing relative to tube <b>102</b>. The viewing scope may also have a guidable tip that can be deflected or rotated by manipulating an actuator on a proximal end of tube <b>102</b>. This type of scope is commercially available from Baxter Healthcare Corp. of Deerfield, Ill., or Origin Medsystems, Inc. of Menlo Park, Calif.
As shown in <figref idref="DRAWINGS">FIG. 4</figref>, viewing scope <b>100</b> further includes a scope adaptor <b>110</b> for coupling viewing scope <b>100</b> to wrist unit adaptor <b>52</b>. Scope adaptor <b>110</b> is sterilizable, ETO and autoclavable, and it includes a plurality of motion feed-throughs (not shown) for transferring motion from drive assembly <b>40</b> to scope <b>100</b>. In the preferred configuration, the motion includes pitch and yaw motion, rotation about the Z-axis, and movement along the Z-axis.
Referring now to <figref idref="DRAWINGS">FIGS. 5 and 6</figref>, forearm assembly <b>46</b> will be described in further detail. As shown in <figref idref="DRAWINGS">FIG. 5</figref>, forearm assembly <b>46</b> includes a housing <b>120</b> fixed to arm <b>42</b> and a movable carriage <b>122</b> slidably coupled to housing <b>120</b>. Carriage <b>122</b> slidably mounts wrist unit adaptor <b>52</b> to housing <b>120</b> for moving wrist unit adaptor <b>52</b> and wrist unit <b>20</b> in the Z-direction. In addition, carriage <b>122</b> defines a number of openings <b>123</b> for transferring motion and electrical signals from forearm assembly <b>46</b> to wrist unit adaptor <b>52</b>. As shown in <figref idref="DRAWINGS">FIG. 6</figref>, a plurality of rotatable shafts <b>124</b> are mounted within housing <b>120</b> for transferring motion from arm <b>42</b> through openings <b>123</b> to wrist unit adaptor <b>52</b> and wrist unit <b>22</b>. Rotating shafts <b>124</b> preferably provide at least four degrees of freedom to wrist unit <b>22</b>, including yaw and pitch motion of surgical tool <b>24</b> about wrist <b>60</b> of wrist unit <b>22</b>, rotation of wrist unit <b>22</b> about the Z-axis and actuation of tool <b>24</b>. The system may also be configured to provide more or less degrees of freedom, if desired. Actuation of tool <b>24</b> may include a variety of motions, such as opening and closing jaws, graspers or scissors, applying clips or staples and the like. Motion of wrist unit <b>22</b> and tool <b>24</b> in the Z direction is provided by a pair of carriage cable drives <b>126</b> extending between rotatable pulleys <b>128</b>, <b>129</b> on either end of forearm housing <b>120</b>. Cable drives <b>126</b> function to move carriage <b>122</b> and wrist unit <b>22</b> in the Z direction relative to forearm housing <b>120</b>.
As shown in <figref idref="DRAWINGS">FIG. 6</figref>, distal end <b>48</b> of arm <b>42</b> includes a coupling assembly <b>130</b> having a plurality of motion feed-throughs <b>132</b> for transferring motion from arm <b>42</b> to forearm assembly <b>46</b>. In addition, coupling assembly <b>130</b> includes a number of electrical connectors (not shown) for transferring electrical signals from arm <b>42</b> to wrist unit <b>22</b>. Similarly, wrist unit adaptor <b>52</b> includes a plurality of motion feed-throughs (not shown) and electrical connections (not shown) for transferring motion, and for sending and receiving electrical signals to and from wrist unit <b>22</b> (e.g., for sending and receiving force and torque feedback signals from the surgical site to controllers <b>12</b>). The components on either side of coupling assembly <b>130</b> and wrist unit adaptor <b>52</b> have a finite range of motion. Usually, this range of motion will be at least 1 revolution and preferably greater than 1 revolution. These ranges of motion are aligned with each other when the forearm assembly <b>46</b> is mechanically coupled to the coupling assembly <b>130</b> and when wrist unit adaptor <b>52</b> is mechanically coupled to the forearm <b>46</b>.
Referring to <figref idref="DRAWINGS">FIG. 7</figref>, wrist unit <b>22</b> will now be described in further detail. As shown, wrist unit <b>22</b> includes a hollow shaft <b>56</b> having a cap <b>58</b> attached to its proximal end and a wrist <b>60</b> attached to its distal end. Wrist <b>60</b> includes a coupling (not shown) for removably coupling a variety of surgical tools <b>24</b> to shaft <b>56</b>. Shaft <b>56</b> is rotatably coupled to cap <b>58</b> for providing rotation of shaft <b>56</b> and tool <b>24</b> about the longitudinal axis of shaft <b>56</b> (i.e., the Z axis). Cap <b>58</b> houses a mechanism (not shown) for transferring motion from wrist unit adaptor <b>52</b> to drive cables (not shown) within shaft <b>56</b>. The drive cables are suitably coupled to drive pulleys within shaft <b>56</b> to pivot tool <b>24</b> about wrist <b>60</b>, and to actuate end effectors <b>140</b> on tool <b>24</b>. Wrist <b>60</b> may also be operated by other mechanisms, such as differential gears, push-rods, or the like.
Tool <b>24</b> is removably coupled to wrist <b>60</b> of wrist unit <b>22</b>. Tool <b>24</b> will preferably include an end effector <b>65</b> (<figref idref="DRAWINGS">FIGS. 3A and 3B</figref>) having a tactile sensor array (not shown) for providing tactile feedback to the surgeon. Tool <b>24</b> may include a variety of articulated tools, such as jaws, scissors, graspers, needle holders, micro dissectors, staple appliers, tackers, suction irrigation tools, clip appliers, that have end effectors driven by wire links, eccentric cams, push-rods or other mechanisms. In addition, tool <b>24</b> may comprise a non-articulated instrument, such as cutting blades, probes, irrigators, catheters or suction orifices. Alternatively, tool <b>24</b> may comprise an electrosurgical probe for ablating, resecting, cutting or coagulating tissue. In the latter embodiment, wrist unit <b>22</b> will include a conductive element, such as a proximal banana plug coupled to a lead wire or rod extending through shaft <b>56</b> to tool <b>24</b>.
Referring to <figref idref="DRAWINGS">FIGS. 4 and 8</figref>, a specific configuration of the drive and control component of the present invention (i.e., the robotic arm <b>42</b> and drive assembly <b>40</b>) will be described in further detail. As discussed above, arm <b>42</b> and drive assembly <b>40</b> are rotatably coupled about a pair of pins <b>150</b> extending from mounting bracket <b>44</b>. Arm <b>42</b> preferably comprises an elongate, substantially rigid body <b>152</b> with a distal end <b>48</b> coupled to forearm assembly <b>48</b> and a proximal end <b>154</b> pivotally coupled to drive assembly <b>40</b> and bracket <b>44</b> for rotation about pitch and yaw or the X and Y axes (note that the Y axis is perpendicular to the page and extends through point <b>45</b>, see <figref idref="DRAWINGS">FIG. 8</figref>). Arm <b>40</b> may have other configurations, such as an elbow arm (similar to the human arm), prismatic arm (straight extendable) or the like. A stationary yaw motor <b>156</b> is mounted to mounting bracket <b>44</b> for rotating arm <b>42</b> and drive assembly <b>40</b> about the X-axis. Drive assembly <b>40</b> also includes a pitch motor <b>158</b> coupled to arm <b>42</b> for rotating arm about the Y axis. A pair of substantially rigid linkage elements <b>160</b>, <b>124</b> extend from bracket <b>44</b> to robotic arm <b>42</b> to pivotally couple arm <b>42</b> to bracket <b>44</b> about Y-axis. One of the linkage elements <b>160</b> is pivotally coupled to arm <b>42</b>, and the other linkage element <b>124</b> is pivotally coupled to a third linkage element <b>164</b> extending parallel to arm <b>42</b>. Preferably, robotic arm <b>42</b> is a channel shaped rigid element that at least partially houses the third linkage element <b>164</b>. The linkage elements <b>160</b>, <b>124</b> and <b>164</b> and arm <b>42</b> form a parallelogram linkage in which the members are connected together in a parallelogram for relative movement only in the plane formed by the members.
The Z-axis of wrist unit <b>22</b> held at the distal end <b>48</b> of arm <b>42</b> intersects the x axis of the parallelogram linkage described above. Wrist unit <b>22</b> has a remote center of spherical rotation about the position indicated by the numeral <b>45</b> in <figref idref="DRAWINGS">FIG. 8</figref>. Thus, the distal end of wrist unit <b>22</b> can be rotated about its own axis or the X and Y axes while the remote center of rotation <b>45</b> remains at the same location. A more complete description of a remote center positioning device can be found in U.S. patent application Ser. No. 08/504,301, filed Jul. 20, 1995, now U.S. Pat. No. 5,931,832, the complete disclosure of which is incorporated herein by reference for all purposes. It should be noted that arm <b>42</b> and drive assembly <b>40</b> may be used with a broad range of positioning devices other than that described above and shown in <figref idref="DRAWINGS">FIG. 8</figref>, such as a stereotaxic positioner, a fixed gimbal, or the like.
Referring again to <figref idref="DRAWINGS">FIG. 8</figref>, drive assembly <b>40</b> further includes a plurality of drive motors <b>170</b> coupled to arm <b>42</b> for rotation therewith. Pitch and yaw motors <b>156</b>, <b>158</b> control the motion of arm <b>42</b> (and drive motors <b>170</b>) about the X and Y axes and drive motors <b>170</b> control the motion of wrist unit <b>22</b> and surgical tool <b>24</b>. Preferably, at least five drive motors <b>170</b> are coupled to arm <b>42</b> for providing at least five degrees of freedom to wrist unit <b>22</b>. Drive motors <b>170</b> will preferably include encoders (not shown) for responding to servomechanism <b>16</b> and force sensors (not shown) for transmitting force and torque feedback to the surgeon S. As discussed above, the five degrees of freedom preferably include movement of carriage <b>122</b> and wrist unit <b>22</b> in the Z-direction, rotation of wrist unit <b>22</b> about the Z-axis, pitch and yaw rotation of surgical tool <b>24</b> around wrist <b>60</b> and actuation of tool <b>24</b>.
As shown, cables <b>172</b> extend from each motor <b>170</b> around a motor drive pulley <b>174</b>, an idler pulley <b>176</b> within arm <b>42</b> and along a relatively large pot capstan <b>178</b> to minimize the effect of friction torque on cables <b>172</b>. The cables <b>172</b> each extend around another idler pulley <b>180</b> at distal end <b>48</b> of arm <b>42</b>, around a coupling drive pulley <b>182</b> and back to the motor <b>170</b>. The cables <b>172</b> will preferably be tensioned at the motor drive pulley <b>174</b> and anchored there as well as at the coupling drive pulley <b>182</b>. As shown in <figref idref="DRAWINGS">FIG. 8</figref>, coupling drive pulley <b>182</b> is connected to a plurality of smaller pulleys <b>184</b> within coupling assembly <b>130</b> via a plurality of cables <b>186</b> for transferring motion from the motors <b>170</b> to wrist unit adaptor <b>52</b>.
A method for performing a surgical procedure on a patient according to the present invention will now be described with reference to <figref idref="DRAWINGS">FIGS. 1-8</figref>. As shown in <figref idref="DRAWINGS">FIG. 2</figref>, mounting joints <b>30</b> are attached to receptacle <b>32</b>, which is attached to the operating table O by sliding mounting arm <b>34</b> along rail <b>36</b>. Each manipulator assembly <b>4</b> is then attached to its respective mounting joint <b>30</b> and articulated into the proper position and orientation relative to the patient P. Receptacles <b>32</b> are then coupled to servomechanism <b>16</b> and other systems that may be required during the surgical procedure, such as an RF power supply, a suction/irrigation system, etc. Sterile drapes <b>70</b> are placed over the manipulator assemblies <b>4</b> before, during, or after the patient has been anesthetized (<figref idref="DRAWINGS">FIG. 3A</figref>). To prepare for the surgical procedure, manipulator assemblies <b>4</b> may or may not be chemically cleaned prior to covering them with drapes <b>70</b>. Wrist unit adapters <b>52</b>, cannula adapters <b>64</b>, and scope adapters <b>110</b> are snapped onto forearm assemblies <b>46</b> of manipulator assemblies <b>4</b> (see <figref idref="DRAWINGS">FIGS. 3B and 5</figref>). The number and relative positions of scope adapters <b>110</b> and wrist unit adapters <b>52</b> will, of course, depend on the individual surgical procedure (e.g., cannula adapters <b>64</b> may not be required for open surgical procedures).
During the surgical procedure, surgical instrument assemblies <b>20</b> are coupled to their respective manipulator assemblies <b>4</b> by laterally urging each respective wrist unit shaft <b>56</b> through opening <b>80</b> of wrist unit adaptor <b>52</b>. Each wrist unit <b>22</b> will have suitable identification means (not shown) to quickly and easily indicate what type of tool <b>24</b> is connected to the wrist unit <b>22</b>. When the surgeon wishes to change surgical tools <b>24</b>, he or she manipulates controller(s) <b>12</b> so that carriage <b>122</b> moves to a top or proximal position of travel along forearm assembly <b>46</b> (see <figref idref="DRAWINGS">FIG. 3B</figref>). In this position, surgical tool <b>24</b> is within cannula <b>66</b> or during open procedures, removed from the surgical site. The assistant(s) A then pulls upward on wrist cap <b>58</b> to release the latch (not shown), thereby allowing wrist unit <b>22</b> to slide further upwards and out of cannula <b>66</b>. The assistant(s) A may then pull wrist unit <b>22</b> laterally to decouple it from wrist unit adaptor <b>52</b>. When wrist unit <b>22</b> is no longer coupled to adaptor <b>52</b>, the control mechanism understands that the system is in “tool change mode”, and drives carriage <b>122</b> to the proximal position if it has not already been moved there by the surgeon.
To couple another surgical instrument assembly <b>20</b> to manipulator assembly <b>4</b>, the assistant(s) A grabs another assembly <b>20</b> from table T, laterally urges wrist unit shaft <b>56</b> into opening <b>80</b> of wrist unit adaptor <b>52</b>, and then moves wrist unit <b>22</b> downward so that surgical tool <b>24</b> resides within cannula <b>66</b> (see <figref idref="DRAWINGS">FIGS. 1 and 3B</figref>). This downward movement of wrist unit <b>22</b> automatically mates the electrical couplings and motion feed-throughs (not shown) within wrist cap <b>58</b> and wrist unit adaptor <b>52</b>. The system may include a control mechanism configured to lock carriage <b>122</b> travel at the top or proximal position, e.g., by actuating a brake (not shown), until the couplings are mated and wrist unit <b>22</b> is no longer being moved downward. At this point, the surgeon S may continue the surgical procedure.
The system and method of the present invention preferably includes a mechanism for counting the number of times wrist unit <b>22</b> is decoupled and coupled from wrist unit adaptor <b>52</b>. In this manner, the manufacturer may limit the number of times wrist unit <b>22</b> can be used. In a specific configuration, an integrated circuit chip (not shown) is housed within wrist cap <b>58</b>. The circuit chip counts the number of times wrist unit <b>22</b> is coupled to wrist unit adaptor <b>52</b>, e.g., 20 times, and a warning shows up on the surgeon's console C. The control system then downgrades the performance of the system by reducing the load it can deliver or increasing apparent backlash.
Referring now to <figref idref="DRAWINGS">FIGS. 9A-9B</figref> and <b>10</b>A-<b>10</b>B, a robotic surgical system <b>200</b> including a robotic surgical manipulator <b>204</b> that is fully covered by a sterile drape <b>270</b> is shown in accordance with another embodiment of the present invention. The present invention provides a sterile adaptor integrated with a sterile drape for draping portions of a telerobotic surgical system to maintain a sterile barrier between the sterile surgical field and the non-sterile robotic system while also providing an interface for transferring mechanical and electrical energy and signals between a surgical instrument and the robotic system. Advantageously, the present invention allows a user to repeatedly and easily install and remove surgical instruments on the system while maintaining a sterile barrier between the sterile surgical instrument and the non-sterile robotic system.
<figref idref="DRAWINGS">FIG. 9A</figref> shows a surgical instrument <b>250</b> installed on a instrument sterile adaptor (ISA) <b>300</b> integrated with sterile drape <b>270</b> in accordance with an embodiment of the present invention. ISA <b>300</b> is in turn operably coupled to an adaptor receiving portion <b>500</b> of the manipulator <b>204</b> (e.g., on the forearm <b>246</b>. <figref idref="DRAWINGS">FIG. 9B</figref> is a side view of the robotic surgical manipulator of <figref idref="DRAWINGS">FIG. 9A</figref> without a sterile drape portion (except ISA <b>300</b> is shown) to illustrate a multiple degree of freedom arm coupling a driving assembly with ISA <b>300</b>, an operably coupled surgical tool or instrument <b>250</b>, a surgical accessory clamp <b>264</b>, and an operably coupled surgical accessory <b>266</b>. <figref idref="DRAWINGS">FIGS. 10A and 10B</figref> illustrate ISA <b>300</b> (integrated with sterile drape <b>270</b>) and accessory clamp <b>264</b> without surgical instrument <b>250</b> and without surgical accessory <b>266</b>, <figref idref="DRAWINGS">FIG. 10B</figref> being shown without drape <b>270</b>. In one embodiment, ISA <b>300</b> may be permanently attached to the sterile drape by means of a film adhesive material which is impulse heat sealed and/or attached using adhesive film to the sterile drape.
System <b>200</b> is similar to the system shown and described above with respect to <figref idref="DRAWINGS">FIGS. 1-8</figref> but adaptors (e.g., a wrist unit adaptor or a cannula adaptor) do not extend through holes in drape <b>270</b> to interface with a surgical instrument in the sterile field. Instead, ISA <b>300</b> is integrated with the sterile drape <b>270</b>, and a portion of drape <b>270</b> effectively shields accessory clamp <b>264</b> from the sterile field of the surgery such that manipulator <b>204</b> is substantially fully covered by drape <b>270</b> during the procedure. In one embodiment, the drape is completely disposable. Advantageously, ISA <b>300</b> and accessory clamp <b>264</b> are not required to be sterilized or replaced prior to or after a surgical procedure, thus allowing for cost savings, and since there is substantially full coverage by the sterile drape, system <b>200</b> is better shielded from the sterile field allowing for greater insulation of the system equipment and protection for the patient.
The same or similar manipulator assembly <b>4</b> including drive assembly <b>40</b>, arm <b>42</b>, forearm assembly <b>46</b>, wrist unit adaptors <b>52</b>, wrist units <b>22</b>, and tools <b>24</b> (with the same or similar functionality) described above may be used within system <b>200</b> and with ISA <b>300</b> and accessory clamp <b>264</b>, and repeated description of the same or similar part(s) is omitted. However, a different drive assembly <b>240</b>, arm <b>242</b>, forearm assembly <b>246</b>, and interface <b>252</b> to actuate tool <b>224</b> with shaft <b>256</b> and end effectors <b>265</b> is illustrated in <figref idref="DRAWINGS">FIGS. 9A-9B</figref> and <b>10</b>A-<b>10</b>B. Embodiments of drive assembly <b>240</b>, arm <b>242</b>, forearm assembly <b>246</b>, and other applicable parts are described for example in U.S. Pat. Nos. 6,331,181, 6,491,701, and 6,770,081, the full disclosures of which (including disclosures incorporated by reference therein) are incorporated herein by reference for all purposes.
Embodiments of applicable surgical instruments <b>250</b>, interfaces <b>252</b>, adaptors, tools, or accessories are also described for example in U.S. Pat. Nos. 6,331,181, 6,491,701, and 6,770,081, the full disclosures of which (including disclosures incorporated by reference therein) are incorporated by reference herein for all purposes. It is noted that various surgical instruments may be used in accordance with the present invention, including but not limited to articulated tools with end effectors, such as jaws, scissors, graspers, needle holders, micro-dissectors, staple appliers, tackers, suction irrigation tools, and clip appliers, and non-articulated tools, such as cutting blades, cautery probes, irrigators, catheters, and suction orifices. Such surgical instruments are commercially available from Intuitive Surgical, Inc. of Sunnyvale, Calif.
Referring now to <figref idref="DRAWINGS">FIGS. 11A-11M</figref>, a patient side manipulator (PSM) drape package <b>400</b> including a PSM drape <b>404</b> that is part of sterile drape <b>70</b> (described above with reference to <figref idref="DRAWINGS">FIG. 3A</figref>) is shown. PSM drape <b>404</b> may be a connected or disconnected section of sterile drape <b>70</b>. <figref idref="DRAWINGS">FIG. 11A</figref> shows PSM drape package <b>400</b> including a PSM drape pouch <b>402</b> with PSM drape <b>404</b> folded inside. The PSM drape is designed to establish a sterile barrier between the non-sterile PSM arms and the sterile field of the surgical procedure. PSM drape <b>404</b> includes an integrated instrument sterile adaptor (ISA) <b>406</b> permanently mounted on the drape, with the complete assembly including the ISA, which is used to engage a surgical tool. Advantageously, various features of the PSM drape aid the draping and installation process.
<figref idref="DRAWINGS">FIG. 11B</figref> shows PSM drape <b>404</b> removed from pouch <b>402</b>. <figref idref="DRAWINGS">FIG. 11C</figref> shows an example of ISA <b>406</b> permanently mounted to PSM drape <b>404</b> proximate a closed end of PSM drape <b>404</b>. <figref idref="DRAWINGS">FIG. 11D</figref> shows tear strips <b>408</b> that define the main hole in the folded PSM drape and folded flaps <b>410</b>. <figref idref="DRAWINGS">FIG. 11E</figref> shows flaps <b>410</b> unfolded, and <figref idref="DRAWINGS">FIG. 11F</figref> shows PSM drape <b>404</b> completely unfolded. PSM drape <b>404</b> is packaged so that the folded drape can be first placed over the PSM arm and then the permanently mounted ISA <b>406</b> is attached to the PSM arm by first locating a front tongue feature into a bracket on the PSM arm followed by swinging the other end of the sterile adaptor until it engages a latch on the PSM arm. PSM drape <b>404</b> is maintained in this initial position by using tear strips <b>408</b> which allow for the controlled unfolding of the drape by tearing when pulled on with the necessary force. The user pulls the drape along the length of the PSM arm by placing their hands in integral cuffs <b>412</b> (<figref idref="DRAWINGS">FIG. 11G</figref>) and pulling the drape along the PSM arm.
FIGS. <b>11</b>G<b>1</b> and <b>11</b>G<b>2</b> show an integral cuff <b>412</b> at the open end of PSM drape <b>404</b>, the edge of cuff <b>412</b> including a blue tape <b>411</b>. The sterile scrub nurse may place his or her hands into the cuff when pulling the PSM drape along the PSM arm, and by using the cuff, the user is assured that their hands are not touching something that is non-sterile as they work their way along the PSM arm. Blue tape <b>411</b> acts as a physical marker on the drape to designate the sterile and non-sterile ends. By having this marker, a non-sterile person can know to pull on the non-sterile side when assisting the sterile scrub nurse.
<figref idref="DRAWINGS">FIG. 11H</figref> shows straps <b>414</b> on the drape to help control the drape and reduce the visual size of the drape (i.e., reduce the volume of or space taken up by the unfolded drape). One strap is proximate the cannula mount area, another strap is proximate a “link <b>3</b>” of the PSM arm, and another strap is along a “setup arm” (e.g., arm <b>42</b> of <figref idref="DRAWINGS">FIGS. 4 and 5</figref>) onto which the PSM arm is mounted.
<figref idref="DRAWINGS">FIG. 11I</figref> shows strips <b>416</b> along the insertion axis and a cannula mount pouch <b>418</b>. A cannula mount pouch that may be used is disclosed in co-pending U.S. patent application Ser. No. 11/240,087, filed Sep. 30, 2005, the contents of which is incorporated by reference herein for all purposes. Strips <b>416</b> are malleable strips on the drape in an insertion axis area. Strips <b>416</b> are attached to the drape between the sterile adaptor and the cannula mount area. Once the drape is installed on the PSM arm, the user can deform the malleable strips <b>416</b> to help fold back excess drape material. By being able to fold back and secure excess drape material, the drape can be made to closely fit the shape of the PSM arm. Advantageously, this reduces the visual size of the system and thereby allows more visibility of the patient and their surroundings to the surgeon or other user(s). Strips <b>416</b> are also sufficiently malleable to be able to open up to allow the system to achieve maximum range of motion without tearing the drape.
<figref idref="DRAWINGS">FIG. 11J</figref> shows PSM drape <b>404</b> over a portion of PSM arm <b>417</b> and a sterile adaptor <b>406</b> in place prior to strips <b>416</b> being bent back by the user. <figref idref="DRAWINGS">FIG. 11K</figref> shows strips <b>416</b> after being bent back by the user such that PSM drape <b>404</b> more closely fits the shape of the PSM arm, thereby reducing the size of the system. <figref idref="DRAWINGS">FIG. 11L</figref> shows another view of the strips <b>416</b> which are pliable enough to be opened for maximum range of motion and which can be reshaped by the user as desired during the procedure.
Drape <b>400</b> described above is preferably comprised of material of sufficient rigidity and strength to allow proper placement over a PSM arm and to resist tearing even under application of cyclical loads in various directions, but are preferably comprised of material of sufficient flexibility to allow movement with the active sections of the manipulator arms. Drape <b>400</b> may be comprised of various durable materials, and in one example is comprised of polyethylene, polyurethane, polycarbonate, or mixtures thereof. In one embodiment, drape <b>400</b> can be vacuum formed as part of a single drape or as separate drapes that can be attached to the main sterile drape <b>70</b> via adhesive, heat, RF welding, or other means. In another embodiment, drape <b>400</b> may be used as disconnected drapes (but possibly adjacent to one another or with overlap) to cover different portions of the surgical robot system.
ISA <b>300</b>, adaptor receiving portion <b>500</b>, and installation/engagement between ISA <b>300</b> and adaptor receiving portion <b>500</b> and between surgical instrument <b>250</b> and ISA <b>300</b> will now be described in greater detail.
Referring to <figref idref="DRAWINGS">FIGS. 12A</figref>, <b>12</b>B, and <b>12</b>C, a top perspective view, a bottom perspective view, and a sectional view of ISA <b>300</b>, respectively, are illustrated in accordance with an embodiment of the present invention. ISA <b>300</b> includes a housing <b>302</b>, a disc <b>304</b>, a top retractor plate <b>306</b>, an instrument stop feature <b>308</b> of housing <b>302</b>, a rail feature <b>301</b> of housing <b>302</b>, a contact <b>310</b>, and a bottom retractor plate <b>312</b>. Top retractor plate <b>306</b> and bottom retractor plate <b>312</b> form a retractor plate assembly <b>313</b> which moves relative to housing <b>302</b>. Discs <b>304</b> are captured inside of retractor plate assembly <b>313</b> and move relative to the assembly.
<figref idref="DRAWINGS">FIG. 13</figref> illustrates a close up section view of a contact <b>310</b>, which is insert molded into the housing in one embodiment.
<figref idref="DRAWINGS">FIGS. 14A and 14B</figref> illustrate close up perspective top and bottom views of disc <b>304</b>, respectively, which includes a tooth <b>314</b> at the base of disc <b>304</b>, a hole <b>316</b> in the body of disc <b>304</b> for accepting pins <b>253</b> of a surgical instrument <b>250</b> (see <figref idref="DRAWINGS">FIGS. 17D and 17E</figref>), a hole <b>317</b> in the bottom of disc <b>304</b> for receiving pins <b>505</b> of spring loaded inputs <b>504</b> (see <figref idref="DRAWINGS">FIG. 16</figref>), and a tab <b>315</b> for moving disc <b>304</b> out of a dead zone, in accordance with an embodiment of the present invention. In this embodiment ISA <b>300</b> includes four discs <b>304</b> with each disc <b>304</b> including four teeth <b>314</b> and two holes <b>316</b>. The four teeth <b>314</b> are placed 90 degrees apart in one embodiment. It is noted that in other embodiments, more or less discs, teeth, and slots are possible but need to operably couple to an adaptor receiving portion on the manipulator and a surgical instrument.
<figref idref="DRAWINGS">FIGS. 15A and 15B</figref> illustrate top and bottom perspective views of top retractor plate <b>306</b> in accordance with an embodiment of the present invention. Top retractor plate <b>306</b> includes a bar <b>318</b> for engaging the retractor plate and the retractor plate assembly and a tooth <b>319</b> for mating with a tooth <b>314</b> of disc <b>304</b> depending on relative position. As shown, top retractor plate <b>306</b> includes four apertures <b>307</b> for the four discs <b>304</b>
<figref idref="DRAWINGS">FIG. 16</figref> illustrates a perspective view of an adaptor receiving portion <b>500</b> of a manipulator <b>204</b> (e.g., a PSM) in accordance with an embodiment of the present invention. Adaptor receiving portion <b>500</b> includes a shroud <b>502</b> to isolate electrical contacts <b>510</b>, a spring loaded input <b>504</b> having a pin <b>505</b>, a spring plunger <b>506</b>, and a bracket <b>508</b> to hold ISA <b>300</b> in place. In this embodiment, adaptor receiving portion <b>500</b> includes four spring loaded inputs <b>504</b> with each having two pins <b>505</b>, and four spring plungers <b>506</b>.
Referring now to <figref idref="DRAWINGS">FIGS. 17A through 17F</figref>, installation/engagement of ISA <b>300</b> to adaptor receiving portion <b>500</b>, installation/engagement of surgical instrument <b>250</b> to ISA <b>300</b>, and removal of surgical instrument <b>250</b> from ISA <b>300</b> are illustrated in accordance with an embodiment of the present invention.
<figref idref="DRAWINGS">FIG. 17A</figref> shows ISA <b>300</b> installed and engaged with adaptor receiving portion <b>500</b> of manipulator <b>204</b>. ISA contacts <b>310</b> are coupled to manipulator contacts <b>510</b>, discs <b>304</b> are engaged with spring loaded inputs <b>504</b>, bottom retractor plate <b>312</b> is engaged with spring plungers <b>506</b>, and instrument stop feature <b>308</b> mates with bracket <b>508</b>. Instrument stop feature <b>308</b> allows for stopping of the instrument (for patient safety) if the user misses the rails <b>301</b> when installing the instrument onto the ISA. The instrument is fully stopped by bar <b>318</b> on top retractor plate <b>306</b> when installed. Prior to installation, spring loaded inputs <b>504</b> and spring plungers <b>506</b> are at their most extended position, and discs <b>304</b> of the ISA are free to rotate to any random location within the retractor plate assembly. In one embodiment, to install ISA <b>300</b> onto adaptor receiving portion <b>500</b>, the user places the front section of the ISA housing into a bracket and swings the back end down thereby engaging a latch <b>511</b>.
In this installed but pre-engaged position, discs <b>304</b> are pressed upward against top retractor plate <b>306</b> by spring loaded inputs <b>504</b>, and retractor plate assembly <b>313</b> is pressed upward by spring loaded inputs <b>504</b> and spring plungers <b>506</b>. In each disc location (aperture <b>307</b> of retractor plate <b>306</b>), there is one tooth <b>319</b> on the retractor plate <b>306</b> which engages with teeth <b>314</b> of disc <b>304</b>. The teeth configuration has multiple functions, one of which is to push discs <b>304</b> out of a “dead zone” which is an angular orientation where the holes <b>317</b> in the bottom of disc <b>304</b> are in a position where they may not mate with pins <b>505</b> of spring loaded inputs <b>504</b> since they do not rotate through a full 360 degrees. Another function of the teeth configuration is to prevent disc <b>304</b> from rotating more than 90 degrees during the sterile adaptor engagement sequence.
During the engagement sequence, disc teeth <b>314</b> mesh with retractor plate teeth <b>319</b> as spring loaded inputs <b>504</b> are activated to impart movement of disc <b>304</b> through friction between pins <b>505</b> and the bottom surface of disc <b>304</b> and through contact with tab <b>315</b>. The presence of the four teeth <b>314</b> stops this rotational motion of disc <b>304</b>, and pins <b>505</b> are allowed to line up with holes <b>317</b> of disc <b>304</b> as the spring loaded inputs <b>504</b> rotate relative to disc <b>304</b>. As holes <b>317</b> on the bottom of disc <b>304</b> and pins <b>505</b> of spring loaded inputs <b>504</b> align, discs <b>304</b> drop onto spring loaded inputs <b>504</b>. At this point, the teeth <b>319</b> of top retractor plate <b>306</b> clear the teeth <b>314</b> of disc <b>304</b> as disc <b>304</b> is dropped down, thereby allowing disc <b>304</b> to move freely through 360 degrees relative to retractor plate <b>306</b>. When discs <b>304</b> are engaged onto spring loaded inputs <b>504</b>, ISA <b>300</b> is engaged with adaptor receiving portion <b>500</b>.
In one embodiment, the engagement sequence happens in milliseconds after installation of ISA <b>300</b> onto adaptor receiving portion <b>500</b>. As ISA <b>300</b> is swung down into position, electrical contacts <b>310</b> engage electrical contacts <b>510</b> (e.g., pins) such that two initially open circuits on the manipulator <b>204</b> are closed, which activates the ISA engagement sequence. It is noted that the insert-molded contact <b>310</b> in housing <b>302</b> may have multiple electrical paths (vias) which engage with contacts on the adaptor receiving portion <b>500</b>, and which are also used to establish communication with a surgical instrument <b>250</b> via instrument electrical contacts <b>255</b> (<figref idref="DRAWINGS">FIG. 17C</figref>).
<figref idref="DRAWINGS">FIG. 17B</figref> shows surgical instrument <b>250</b> partially installed, and <figref idref="DRAWINGS">FIG. 17C</figref> shows surgical instrument <b>250</b> fully installed and engaged with ISA <b>300</b>. Initially, as the user installs surgical instrument <b>250</b> onto ISA <b>300</b>, retractor plate assembly <b>313</b> is pushed down toward adaptor receiving portion <b>500</b> as top retractor plate <b>306</b> is pressed down by instrument <b>250</b> engaging center bar <b>318</b>. Prior to electrical engagement between instrument <b>250</b> and ISA <b>300</b>, a chamfer on bar <b>318</b> engages a chamfer on the bottom of instrument <b>250</b>, and as these two chamfers are aligned, the instrument is pulled into its home position due to the spring force of the spring loaded inputs and spring plungers. As the instrument is pulled into its home position, retractor plate assembly <b>313</b> begins to rise up into the surgical instrument, and in substantially the same motion, the electrical contacts <b>255</b> of instrument <b>250</b> come into contact with electrical contacts <b>310</b> of ISA <b>300</b>. When instrument <b>250</b> is installed onto ISA <b>300</b>, top retractor plate <b>306</b> is pressing on the bottom of the instrument and bar <b>318</b> is inside a clearance slot in the instrument housing. Prior to instrument engagement, discs <b>304</b> and spring loaded inputs <b>504</b> are pressed away from the instrument since the inputs on the instrument are not engaged with the holes <b>316</b> on the top of disc <b>304</b>.
<figref idref="DRAWINGS">FIGS. 17D and 17E</figref> illustrate an engagement sequence of disc <b>304</b> with instrument <b>250</b>. In <figref idref="DRAWINGS">FIG. 17D</figref>, disc <b>304</b> is not engaged with instrument <b>250</b> until disc <b>304</b> rotates to align with instrument disc <b>251</b>, which is initially in a random position. As previously mentioned with respect to the engagement sequence between ISA <b>300</b> and adaptor receiving portion <b>500</b>, as the electrical contacts of the instrument engage the contacts <b>310</b> of ISA <b>300</b>, a normally open circuit on the ISA is closed which activates the instrument engagement sequence. Spring loaded inputs <b>504</b> and discs <b>304</b> rotate together as an assembly until the holes <b>316</b> of disc <b>304</b> engage with the pins <b>253</b> of instrument disks <b>251</b>. When the holes are aligned with the pins, disc <b>304</b> and spring loaded inputs <b>504</b> is allowed to move upwards. <figref idref="DRAWINGS">FIG. 17E</figref> shows instrument disk <b>251</b> having a pin <b>253</b> which engages with hole <b>316</b> of ISA disk <b>304</b>. At this point instrument <b>250</b> is considered engaged with ISA <b>300</b>. It is noted that other contacts on ISA <b>300</b> may transmit electrical signals between the surgical system and instrument RTI board.
When the instrument is fully installed, it is held in position at three points along its housing. Two points are at the rail features <b>301</b> along the sides of the instrument, and a third point is at the center hold down tab <b>309</b> along the front center of the instrument. Advantageously, by holding down the instrument at three locations, the instrument is not over-constrained and installation and removal is made easier.
<figref idref="DRAWINGS">FIG. 17F</figref> illustrates removal of instrument <b>250</b> (not shown) from ISA <b>300</b>. When the user wants to remove the instrument, levers on either side are squeezed and the instrument is pulled back out of the ISA. The levers on the instrument act on the center bar <b>318</b> of the top retractor plate, which in turn pushes the retractor plate down away from the instrument. As the retractor plate moves further away, the discs <b>304</b> are disengaged from the pins of the instrument allowing for removal of the instrument.
Advantageously, the drapes of the present invention provide for improved installation and interfacing of a surgical instrument with a manipulator arm, improved robustness of the sterile field, and increased visualization of the patient by reducing the size of the drapes with more form fitting features.
Embodiments described above illustrate but do not limit the invention. It should also be understood that numerous modifications and variations are possible in accordance with the principles of the present invention. For example, the number of pins, slots, disks, and teeth may vary but must allow for operable coupling between the ISA, manipulator arm, and surgical instrument. Accordingly, the scope of the invention is defined only by the following claims.
Contents6
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| DE69331789D1 | Germany | D1 | |
| US2002055795A1 | United States of America | A1 | |
| US2002058929A1 | United States of America | A1 | |
| US6394998B1 | United States of America | B1 | |
| US6398726B1 | United States of America | B1 | |
| WO0243569A2 | World Intellectual Property Organization (WIPO) | A2 | |
| US2002072736A1 | United States of America | A1 | |
| US2002082612A1 | United States of America | A1 | |
| US2002091374A1 | United States of America | A1 | |
| US6424885B1 | United States of America | B1 | |
| US2002103476A1 | United States of America | A1 | |
| US2002111621A1 | United States of America | A1 | |
| WO0030548A9 | World Intellectual Property Organization (WIPO) | A9 | |
| US2002120254A1 | United States of America | A1 | |
| US2002120363A1 | United States of America | A1 | |
| US2002128552A1 | United States of America | A1 | |
| US6459926B1 | United States of America | B1 | |
| EP1181627A4 | European Patent Office (EPO) | A4 | |
| US6468265B1 | United States of America | B1 | |
| US6491701B2 | United States of America | B2 | |
| US6493608B1 | United States of America | B1 | |
| EP1269389A1 | European Patent Office (EPO) | A1 | |
| US2003004610A1 | United States of America | A1 |
65 transactions on the USPTO file
Allowed after 1 non-final rejection and 1 final rejection.
- Non-final rejections
- 1
- Final rejections
- 1
- RCEs
- 0
- Appeals
- 0
Over time
Point at a mark for the transactionTransactions
| Event | Code | |
|---|---|---|
| Expire PatentEXP. | EXP. | |
| Maintenance Fee Reminder MailedREM. | REM. | |
| Email NotificationEML_NTR | EML_NTR | |
| Change in Power of Attorney (May Include Associate POA)PA.. | PA.. | |
| Correspondence Address ChangeC.AD | C.AD | |
| Application Is Considered for C of CCOFC | COFC | |
| Mail-Petition Decision - GrantedMP034 | MP034 | |
| Petition Decision - GrantedP034 | P034 | |
| Petition EnteredPET1 | PET1 | |
| Recordation of Patent Grant MailedPGM/ | PGM/ | |
| Patent Issue Date Used in PTA CalculationAllowedPTAC | PTAC | |
| Issue Notification MailedAllowedWPIR | WPIR | |
| Dispatch to FDCD1935 | D1935 | |
| Application Is Considered Ready for IssuePILS | PILS | |
| Printer Rush- No mailingTCPB | TCPB | |
| Issue Fee Payment VerifiedN084 | N084 | |
| Issue Fee Payment ReceivedIFEE | IFEE | |
| Reverse Issue FeeVFEE | VFEE | |
| Entity status set to undiscounted (initial default setting or status change)BIG. | BIG. | |
| Issue Fee Payment ReceivedIFEE | IFEE | |
| Printer Rush- No mailingTCPB | TCPB | |
| Pubs Case Remand to TCPUBTC | PUBTC | |
| Mail Notice of AllowanceAllowedMN/=. | MN/=. | |
| Notice of Allowance Data Verification CompletedAllowedN/=. | N/=. | |
| Date Forwarded to ExaminerFWDX | FWDX | |
| Response after Final ActionA.NE | A.NE | |
| Reference capture on IDSRCAP | RCAP | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Mail Final Rejection (PTOL - 326)Final rejectionMCTFR | MCTFR | |
| Final RejectionFinal rejectionCTFR | CTFR | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Date Forwarded to ExaminerFWDX | FWDX | |
| Response after Non-Final ActionA... | A... | |
| Mail Non-Final RejectionNon-final rejectionMCTNF | MCTNF | |
| Non-Final RejectionNon-final rejectionCTNF | CTNF | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Reference capture on IDSRCAP | RCAP | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| IFW TSS Processing by Tech Center CompleteTSSCOMP | TSSCOMP | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Application Return from OIPEWROIPE | WROIPE | |
| Application Is Now CompleteCOMP | COMP | |
| Application Return TO OIPEROIPE | ROIPE | |
| Application Dispatched from OIPEOIPE | OIPE | |
| Application Is Now CompleteCOMP | COMP | |
| Additional Application Filing FeesADDFLFEE | ADDFLFEE | |
| A statement by one or more inventors satisfying the requirement under 35 USC 115, Oath of the ApplicOATHDECL | OATHDECL | |
| Applicant has submitted new drawings to correct Corrected Papers problemsCORRDRW | CORRDRW | |
| Notice Mailed--Application Incomplete--Filing Date AssignedINCD | INCD | |
| Cleared by OIPE CSRL194 | L194 | |
| IFW Scan & PACR Auto Security ReviewSCAN | SCAN | |
| Initial Exam Team nnIEXX | IEXX |
13 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Lapsed due to failure to pay maintenance feeLapsedFP | FP | |
| Lapse for failure to pay maintenance feesLapsedPATENT EXPIRED FOR FAILURE TO PAY MAINTENANCE FEES (ORIGINAL EVENT CODE: EXP.); ENTITY STATUS OF PATENT OWNER: LARGE ENTITYLAPS | LAPS | |
| Information on status: patent discontinuationPATENT EXPIRED DUE TO NONPAYMENT OF MAINTENANCE FEES UNDER 37 CFR 1.362STCH | STCH | |
| Fee payment procedureMAINTENANCE FEE REMINDER MAILED (ORIGINAL EVENT CODE: REM.); ENTITY STATUS OF PATENT OWNER: LARGE ENTITYFEPP | FEPP | |
| Fee paymentFPAY | FPAY | |
| AssignmentAS | AS | |
| Fee paymentFPAY | FPAY | |
| AssignmentAS | AS | |
| Certificate of correctionCC | CC | |
| Information on status: patent grantGrantedPATENTED CASESTCF | STCF | |
| Fee payment procedurePAYOR NUMBER ASSIGNED (ORIGINAL EVENT CODE: ASPN); ENTITY STATUS OF PATENT OWNER: LARGE ENTITYFEPP | FEPP | |
| AssignmentAS | AS | |
| AssignmentAS | AS |
Numbers
- Publication
- 07666191
- Publication, DOCDB
- 7666191
- Publication, EPODOC
- US7666191
- Application
- 11314040
- Application, DOCDB
- 31404005
- Application, EPODOC
- US20050314040
Titles
- English
- Robotic surgical system with sterile surgical adaptor
Patent term adjustment
- A delay
- +724 daysthe office missed an examination deadline
- B delay
- +430 dayspendency past three years
- Overlap
- −55 daysdelays counted once
- Net adjustment
- 1,099 days
Classification
- CPC, 12
- A61B34/30
- A61B17/00
- A61B2017/00477
- B25J19/0075
- A61B34/71
- A61B90/50
- A61B50/10
- A61B46/10
- A61B34/37
- A61B34/35
- A61B2034/305
- A61B2034/741
- IPC, 1
- A61B19 00
- USPC, 2
- 606130000
- 606001000